MiniMed 630G System with SmartGuard

Automated Insulin Dosing , Threshold Suspend

FDA Premarket Approval P150001 S008

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for adding the guardian sensor (3) and guardian link (3) transmitter to the minimed 630g system with smartguard, as well as lowering the approved age limit from 16 years old to 14 years old.

DeviceMiniMed 630G System with SmartGuard
Classification NameAutomated Insulin Dosing , Threshold Suspend
Generic NameAutomated Insulin Dosing , Threshold Suspend
ApplicantMEDTRONIC MINIMED
Date Received2016-12-14
Decision Date2017-06-02
PMAP150001
SupplementS008
Product CodeOZO
Advisory CommitteeClinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325

Supplemental Filings

Supplement NumberDateSupplement Type
P150001Original Filing
S102 2022-11-16 Special (immediate Track)
S101 2022-11-04 30-day Notice
S100
S099 2022-09-14 Special (immediate Track)
S098 2022-04-01 30-day Notice
S097 2022-03-30 30-day Notice
S096 2022-03-29 30-day Notice
S095
S094
S093 2021-11-17 Special (immediate Track)
S092 2021-09-20 30-day Notice
S091 2021-06-29 30-day Notice
S090 2021-01-27 Special (immediate Track)
S089 2020-11-03 30-day Notice
S088 2020-08-28 Real-time Process
S087 2020-08-04 30-day Notice
S086 2020-05-26 30-day Notice
S085
S084
S083 2020-03-30 30-day Notice
S082 2020-01-08 30-day Notice
S081 2019-12-23 30-day Notice
S080 2019-11-29 30-day Notice
S079 2019-11-27 30-day Notice
S078 2019-11-27 30-day Notice
S077 2019-10-17 30-day Notice
S076 2019-10-11 30-day Notice
S075 2019-09-30 30-day Notice
S074
S073 2019-08-21 30-day Notice
S072 2019-07-15 30-day Notice
S071 2019-06-19 30-day Notice
S070 2019-06-13 30-day Notice
S069 2019-05-21 30-day Notice
S068 2019-05-17 30-day Notice
S067
S066
S065
S064 2019-04-03 30-day Notice
S063 2019-04-01 30-day Notice
S062 2019-02-25 30-day Notice
S061 2019-02-11 30-day Notice
S060
S059 2019-02-01 30-day Notice
S058 2019-01-22 30-day Notice
S057
S056 2018-11-07 30-day Notice
S055 2018-11-07 30-day Notice
S054 2018-11-02 30-day Notice
S053 2018-10-15 30-day Notice
S052 2018-08-31 Real-time Process
S051 2018-07-23 30-day Notice
S050 2018-07-23 Normal 180 Day Track
S049 2018-07-09 30-day Notice
S048 2018-07-02 30-day Notice
S047 2018-06-19 30-day Notice
S046 2018-06-07 Special (immediate Track)
S045 2018-06-04 30-day Notice
S044 2018-05-11 30-day Notice
S043 2018-03-29 30-day Notice
S042 2018-03-26 30-day Notice
S041 2018-03-12 30-day Notice
S040 2018-02-23 30-day Notice
S039 2018-02-09 Real-time Process
S038 2018-02-07 30-day Notice
S037 2018-01-31 30-day Notice
S036 2018-01-30 30-day Notice
S035 2018-01-29 30-day Notice
S034 2018-01-29 30-day Notice
S033 2018-01-23 Special (immediate Track)
S032 2017-12-22 30-day Notice
S031 2017-11-30 Real-time Process
S030 2017-11-24 30-day Notice
S029
S028 2017-10-30 Normal 180 Day Track
S027 2017-10-30 30-day Notice
S026 2017-10-10 30-day Notice
S025 2017-10-06 30-day Notice
S024 2017-09-29 30-day Notice
S023 2017-09-14 30-day Notice
S022 2017-08-04 Real-time Process
S021 2017-08-02 Panel Track
S020 2017-07-21 Real-time Process
S019 2017-07-17 30-day Notice
S018
S017 2017-06-02 Special (immediate Track)
S016 2017-05-30 30-day Notice
S015 2017-05-08 30-day Notice
S014 2017-04-10 30-day Notice
S013 2017-04-07 Real-time Process
S012 2017-03-31 30-day Notice
S011 2017-03-24 30-day Notice
S010
S009 2016-12-23 Real-time Process
S008 2016-12-14 Normal 180 Day Track
S007 2016-12-12 30-day Notice
S006 2016-11-28 30-day Notice
S005 2016-11-28 30-day Notice
S004 2016-11-02 30-day Notice
S003 2016-10-24 Real-time Process
S002 2016-10-14 30-day Notice
S001 2016-09-02 30-day Notice

NIH GUDID Devices

Device IDPMASupp
0193-6262-01 P150001 000
00643169283183 P150001 000
00643169290822 P150001 000
00643169656840 P150001 000
00643169752726 P150001 000
00643169800403 P150001 000
00643169864672 P150001 000
00643169873834 P150001 000
00643169873841 P150001 000
00301936260019 P150001 000
00643169878648 P150001 001
00643169455535 P150001 007
00763000047665 P150001 013
00763000047672 P150001 013
20763000017556 P150001 020
00763000017569 P150001 020
00763000157043 P150001 021
00763000075446 P150001 023
00763000075439 P150001 023
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00763000090197 P150001 028
00763000101527 P150001 028
00763000179632 P150001 031
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00763000166519 P150001 031
00763000256814 P150001 052
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00763000190439 P150001 052
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00763000317591 P150001 065
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00763000316655 P150001 065
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00763000316686 P150001 065
00763000316631 P150001 065
00763000367060 P150001 083
00763000367053 P150001 083
00763000367091 P150001 083

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